TruMedicines Fast-Track SBIR Application ? Project Summary TruMedicines is a Seattle based software technology company that provides the Trumedicines Recognition Authentication Cloud Intelligence (TRACI) mobile software solutions to address requirements of the 2013 Drug Security Act to track, trace, and authenticate of drug packages. Our functional practice areas include mobile app development, image recognition, secure data storage, image retrieval and text to speech messaging. TRACI uses our patented pattern recognition algorithms to authenticate individual addressable drug units (ADUs). This allows ADU tracking, tracing, and authentication, which has never been possible before. The software identifies ADUs, allows users to ?scan a pill to log in? to the system, and provides an interactive device to communicate in real-time directly to study administrators. Through this Phase I SBIR application, TruMedicines will develop a new product, TRACI-4DPS (TRACI for Drug Product Surveillance) to address the FDA-CDER?s interest in collecting usable data on post-marketing drug product use and communications. To complete development and testing of our product, TruMedicines has partnered with investigators from the University of Washington Dept. of Psychiatry & Behavioral Sciences and the Global Medicine Center, to focus on 3 Specific Aims: Aim 1) Develop targeted software to create easy-to-use tools for communication between patients, physicians and health-care providers that will: a) track physician prescribing behavior; b) communicate newly identified risks to patients; and c) collect data on drug-associated events to include in real-time expected, unexpected and adverse events; Aim 2) Develop software to provide advanced statistical analyses and display graphical charts of data resulting from Aim 1 that can be shared with healthcare providers, regulators and researchers. The statistical analyses and graphs will be accessible for: 1) personal use by the patient and healthcare provider(s) and 2) anonymous HIPPA-compliant for regulatory oversight and research studies; and Aim 3) Create a panel of patients, providers, pharmacists and regulators to test, evaluate, and provide feedback on TRACI-4DPS that will be used to refine our product in the Phase II application. Results of the enhanced software development and testing will be used to develop our Phase II SBIR application, which includes testing for feasibility in a small clinical trial that will partner patients with their healthcare provider(s) and physicians. Additionally, we will use the results of our Phase I project to develop our Plan for Commercialization as we believe that our unique product fills a gap in mobile technology for healthcare as a ?personal healthcare assistant? and is particularly suited to the FDA?s challenges in gathering data on drug use surveillance.